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Registration Dossier
Diss Factsheets
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EC number: 211-334-3 | CAS number: 638-38-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 158 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 579 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No inhalative study is available because its necessity was not identified as the substance has a low vapour pressure and large particle size, so not inhalable forms will be formed. So, the most relevant study for the mandatory derivation of this DNEL (Workers, inhalation, systemic effects, long-term) is a chronic (2 a) oral toxicity study on both rats and mice.
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- default (NOAEC is derived from a chronic study study)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no allometric scaling is needed for oral-to-inhalation extrapolation
- AF for other interspecies differences:
- 2
- Justification:
- In this chronic study, already two species were tested and the NOAEC is derived from the more sensitive species, so the uncertainty of interspecies extrapolation is already reduced compared to the default AF
- AF for intraspecies differences:
- 5
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- default (good quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties are identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.57 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 70
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No long-term study on dermal toxicity is available and required, so only oral toxicity data can used.
- AF for dose response relationship:
- 1
- Justification:
- in accordance with the principles given in ECHA guidance R.8.
- AF for differences in duration of exposure:
- 1
- Justification:
- No additional AF needs to be applied since the NOAEL is derived from a chronic study. AF is based on correction for working exposure, i.e. 40 years instead of 75 year life span (=40/75) and 8h instead of 24 exposure (=8/24)
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- default factor for allometric scaling (mouse to human) as given in ECHA guidance R.8
- AF for other interspecies differences:
- 2
- Justification:
- In this chronic study, already two species were tested and the NOAEC is derived from the more sensitive species, so the uncertainty of interspecies extrapolation is already reduced compared to the default AF
- AF for intraspecies differences:
- 5
- Justification:
- default factor as given in ECHA guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- no AF needed since database is of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 521.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No inhalative study is available because its necessity was not identified as the substance has a low vapour pressure and large particle size, so not inhalable forms will be formed. So, the most relevant study for the mandatory derivation of this DNEL (General population, inhalation, systemic effects, long-term) is a chronic (2 a) oral toxicity study on both rats and mice.
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- default (NOAEC is derived from a chronic study study)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no allometric scaling is needed for oral-to-inhalation extrapolation
- AF for other interspecies differences:
- 2
- Justification:
- In this chronic study, already two species were tested and the NOAEC is derived from the more sensitive species, so the uncertainty of interspecies extrapolation is already reduced compared to the default AF
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- default (good quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties are identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 140
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No long-term study on dermal toxicity is available and required, so only oral toxicity data can used.
- AF for dose response relationship:
- 1
- Justification:
- in accordance with the principles given in ECHA guidance R.8.
- AF for differences in duration of exposure:
- 1
- Justification:
- no AF required, available NOAEL already derived from chronic (life-time) study
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- default factor for allometric scaling (mouse to human) as given in ECHA guidance R.8
- AF for other interspecies differences:
- 2
- Justification:
- In this chronic study, already two species were tested and the NOAEC is derived from the more sensitive species, so the uncertainty of interspecies extrapolation is already reduced compared to the default AF
- AF for intraspecies differences:
- 10
- Justification:
- default factor as given in ECHA guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- no AF needed since database is of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- no uncertainties remaining
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 140
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable - NOAEL from chronic oral study
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- default (NOAEC is derived from a chronic study study)
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- default
- AF for other interspecies differences:
- 2
- Justification:
- In this chronic study, already two species were tested and the NOAEC is derived from the more sensitive species, so the uncertainty of interspecies extrapolation is already reduced compared to the default AF
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- default (good quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties are identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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